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Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.
इंटरनेट मानक
“!ान $ एक न' भारत का +नम-ण”Satyanarayan Gangaram Pitroda
“Invent a New India Using Knowledge”
“प0रा1 को छोड न' 5 तरफ”Jawaharlal Nehru
“Step Out From the Old to the New”
“जान1 का अ+धकार, जी1 का अ+धकार”Mazdoor Kisan Shakti Sangathan
“The Right to Information, The Right to Live”
“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता है”Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”
“Invent a New India Using Knowledge”
है”ह”ह
IS 15732-3 (2006): Optics and photonics Medical Endoscopesand endotherapy devices, Part 3: Determination of field of vview and direction of view of endoscopes with optics [MHD1: Surgical Instruments]
IS 15732 (Part 3) :2006ISO 8600-3:1997
Wm9v77m
Indian Standard
OPTICS AND PHOTONICS — MEDICAL ENDOSCOPESAND ENDOTHERAPY DEVICES
PART 3 DETERMINATION OF FIELD OF VIEW AND DIRECTION OF
VIEW OF ENDOSCOPES WITH OPTICS
ICS 11.060.10
0 BIS 2006
BUREAU OF INDIAN STANDARDSMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002
December 2006 Price Group 3
Surgical Instrument Sectional Committee, MHR 01
NATIONAL FOREWORD
This Indian Standard (Part 3) which is identical with ISO 8600-3:1997 ‘Optics and optical instruments —Medical endoscopes and endoscopic accessories — Part 3: Determination of field of view and direction ofview of endoscopes with optics’ issued by the International Organization for Standardization (ISO) was adoptedby the Bureau of Indian Standards on the recommendation of the Surgical Instrument Sectional Committeeand approval of the Medical Equipment and Hospital Planning Division Council.
The text of the ISO Standard has been approved as suitable for publication as an Indian Standard withoutdeviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention isparticularly drawn to the following:
a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as‘Indian Standard’.
b) Comma (,) has been used as a decimal marker in the International Standard while in Indian Standards,the current practice is to use a point (.) as the decimal marker.
Other parts of this standard are:
Part 1 General requirements
Part 4 Determination of maximum width of insertion portion
Amendment No. 1 to the above International Standard has been given at the end of this publication.
For the purpose of deciding whether a particular requirement of this standard is compiled with, the final value,observed or calculated expressing the result of a test or analysis, shall be rounded off in accordance withIS 2:1960 ‘Rules for rounding off numerical values (revised)’. The number of significant places retained in therounded off value should be the same as that of the specified value in this standard.
[S 15732 (Part 3) :2006ISO 8600-3:1997
Indian Standard
OPTICS AND PHOTONICS — MEDICAL ENDOSCOPESAND ENDOTHERAPY DEVICES
PART 3 DETERMINATION OF FIELD OF VIEW AND DIRECTION OFVIEW OF ENDOSCOPES WITH OPTICS
1 Scope
This part of ISO 8600 specifies requirements and recommends test methods for measuring the field of view anddirection of view of endoscopes.
2 Requirements
2.1 Measuring accuracy (field of view)
The minimum accuracy of the test method used to measure the field of view shall be:
k 5 % of the reading for rigid endoscopes;
* 10 YO of the reading for flexible endoscopes.
2.2 Measuring accuracy (direction of view)
The minimum accuracy of the test method used to measure the direction of view shall be:
k 3° for rigid endoscopes;
I 10° for flexible endoscopes.
3 Apparatus
3.1 Optical bench, or equivalent device, to support the optical endoscope being tested and allowing adjustment ofthe central axis of the field of view to the centre of the target to measure the field of view at a distance of 50 mmbetween the distal window surface of the endoscope and the centre of the graduated scale situated at right anglesto the centreline.
3.2 Target holder and protractor, graduated in degrees (see figure 1).
IS 15732 (Part 3) :2006ISO 8600-3:1997
3.3 Target for field of view and direction of view tests, round, having circles showing the field of view /3, indegrees, from a distance of 50 mm computed as
mm = 100 tan$D
and mounted on the device (see figure 2).
Major divisions shall be marked every 10° with the corresponding number in degrees.
Between each major division, four finer marks shall indicate every 2°.
3.4 Illumination source
A white-light target illumination with a minimum intensity of 500 IUX shall be provided, using either the endoscopeillumination or an external source.
4 Test method for field of view and direction of view
The following test method is recommended; however, other test methods may be used if the same results areobtained.
4.1 Mount the target (3.3) into the device according to 3.1.
4.2 Mount the endoscope to be tested in the endoscope holder (3.1) in such a manner that the centre of the distal
window is 50 mm * 0,2 mm from the target centre.
4.3 Adjust the endoscope holder by looking through the endoscope, so that the circles marked on the target andthe circumference of the field of view are centred.
4.4 Determine the largest visible circle and record it as the field of view, in degrees. For a non-circular image, onlysegments of the largest circle may be visible.
4.5 Read and record as the direction of view the angular position, in degrees, of the protractor relative to theperpendicular axis of the endoscope.
4.6 Repeat steps 4.3 to 4.5 until a sufficient number of results have been obtained to verify the required statisticalaccuracy of the endoscope.
2
.—. —____
4
___ ._
IS 15732 (Part 3) :2006ISO 8600-3:1997
!I\ 1
I
I
. .
I90”
I
,
—.0
●
.sJ
I
Figure 1 — Example of a test device (not to scale)
IS 15732 (Part 3) :2006ISO 8600-3:1997
Dimensions in millimstresAnglss in dsgrses
I
13
Ii-\.-””—-”—””—””—”-—””—””—-”— “—”’—--—--—”-—--—”-””-””-””--;./
\.,\.
\. “’”\~.A.~-~”‘“\.. .&”””
Figure 2 — Target for field of view and direction of view teste (not to scale)
4
IS 15732 (Part 3) :2006ISO 8600-3:1997
AMENDMENT 1
Page 1, subclause 3.1
Add the following sentence:
If the working distance of the endoscope, as specified by the manufacturer, is less than 50 mm, then a target
designed to measure field of view at that working distance should be placed at the specified working distance.
Page 2, subclause 3.3
Add the following sentence:
If the working distance of the endoscope, as specified by the manufacturer, is less than 50 mm, then a similartarget, designed to measure field of view at that working distance, should be used.
Page 2, subclause 4.2
Add the following sentence:
If the working distance of the endoscope, as specified by the manufacturer, is less than 50 mm, then theendoscope should be mounted at that working distance * 0,2 mm from the target designed to measure field ofview at that working distance.
5
Bureau of Indian Standards
BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promoteharmonious development of the activities of standardization, marking and quality certification of goodsand attending to connected matters in the country.
Copyright
BIS has the copyright of all its publications. No part of these publications maybe reproduced in any formwithout the prior permission in writing of BIS. This does not preclude the free &e; in the ooursq ‘ofimplementing the standard, of necessary details, such as symbols and sizes, typem grade designations.,Enquiries relating to copyright be addressed to the Director (Publioatiis), 81S.
Review of Indian Standards.
Amendments are issued to standards as the needarises on the baakofcckiwwn*St&Wards are alsoreviewed periodically; a standard along with amendments is reaft%rns+!#t#@s#&t#@@@aw k?dicates thatno changes are needed; if the review indicates ~hat changes are -$,M ~,~ ~ for revkion.Users of Indian Standards should ascertain that they are in pos~ss@r!’&&a ~- mdments oredition by referring to the latest issue of ‘BIS Catdlogue’ and ‘S-laridard$: Mond%iy&!dkkms’.
This Indian Standard has been developed from Doc: No. MHR 01 (0028).
Amendments Issued Since Publication
Amend No. Date of Issue Text Affected
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